Trial Outcomes & Findings for A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors (NCT NCT04032704)

NCT ID: NCT04032704

Last Updated: 2025-03-10

Results Overview

Confirmed ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (\<) 10 millimeter (mm). PR was defined as more than or equal to (\>=) 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have at least 2 post-baseline response assessment (initial response and confirmation scan) were counted as non-responders.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 205 participants
• Primary outcome timeframe: From the first dose of study treatment until the first documented CR or PR or new anticancer therapies or death, whichever occurred first (maximum up to 8.3 months)
• Results posted on: 2025-03-10

Participant Flow

This study had Parts A, B and C. Study was terminated and Part C was not opened. A total of 205 participants were enrolled in Part A (49 participants) and Part B (156 participants) of this study. In Part A all enrolled participants received study intervention while in Part B, 2 participants did not receive study intervention.

Cohorts of study: Cohort 1: small cell lung cancer (SCLC) (Part A, B); Cohort 2: non-SCLC-squamous (NSCLC-squamous) (Part A, B); Cohort 3: NSCLC-nonsquamous (Part A, B); Cohort 4: head & neck squamous cell carcinoma (HNSCC) (Part A, B); Cohort 5: esophageal squamous cell carcinoma (esophageal-squamous) (Part A, B); Cohort 6: gastric & gastroesophageal junction (GEJ) adenocarcinoma (Part A, B); Cohort 7: castration-resistant prostate cancer (CRPC) (Part B); Cohort 8: melanoma (Part B).

Participant milestones

Measure	Part A: Cohort 1, LV 2.5 mg/kg Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk) .	Part A: Cohort 2, LV 2.5 mg/kg Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 1, LV 1.25 mg/kg Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.	Part B: Cohort 2, LV 1.25 mg/kg Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 3, LV 1.25 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.25 mg/kg Participants with HNSCC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 5, LV 1.25 mg/kg Participants with esophageal-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.25 mg/kg Participants with GEJ were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
Part A STARTED	10	2	13	7	5	12	0	0	0	0	0	0	0	0	0	0	0	0
Part A COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part A NOT COMPLETED	10	2	13	7	5	12	0	0	0	0	0	0	0	0	0	0	0	0
Part B STARTED	0	0	0	0	0	0	16	16	19	14	17	21	14	31	2	2	2	2
Part B COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part B NOT COMPLETED	0	0	0	0	0	0	16	16	19	14	17	21	14	31	2	2	2	2

Reasons for withdrawal

Measure	Part A: Cohort 1, LV 2.5 mg/kg Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk) .	Part A: Cohort 2, LV 2.5 mg/kg Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 1, LV 1.25 mg/kg Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.	Part B: Cohort 2, LV 1.25 mg/kg Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 3, LV 1.25 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.25 mg/kg Participants with HNSCC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 5, LV 1.25 mg/kg Participants with esophageal-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.25 mg/kg Participants with GEJ were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
Part A Withdrawal by Subject	0	0	3	0	1	7	0	0	0	0	0	0	0	0	0	0	0	0
Part A Lost to Follow-up	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part A Death	9	2	10	7	4	5	0	0	0	0	0	0	0	0	0	0	0	0
Part B Other	0	0	0	0	0	0	0	1	2	1	1	1	5	13	0	0	0	0
Part B Study termination by Sponsor	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Part B Withdrawal by Subject	0	0	0	0	0	0	3	2	2	1	4	6	2	1	0	1	0	0
Part B Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Part B Death	0	0	0	0	0	0	13	13	14	12	12	13	7	17	2	1	2	2

Baseline Characteristics

A Study of Ladiratuzumab Vedotin in Advanced Solid Tumors

Baseline characteristics by cohort

Measure	Part A: Cohort 1, LV 2.5 mg/kg n=10 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=13 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=7 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=5 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 1, LV 1.25 mg/kg n=16 Participants Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.	Part B: Cohort 2, LV 1.25 mg/kg n=16 Participants Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 3, LV 1.25 mg/kg n=19 Participants Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.25 mg/kg n=14 Participants Participants with HNSCC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 5, LV 1.25 mg/kg n=17 Participants Participants with esophageal-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.25 mg/kg n=21 Participants Participants with GEJ were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 7, LV 1.25 mg/kg n=13 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=30 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.	Part B: Cohort 3, LV 1.0 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=2 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg n=2 Participants Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Total n=203 Participants Total of all reporting groups
Age, Continuous	63.7 Years STANDARD_DEVIATION 9.5 • n=5 Participants	80.5 Years STANDARD_DEVIATION 4.9 • n=7 Participants	67.2 Years STANDARD_DEVIATION 13.7 • n=5 Participants	63.1 Years STANDARD_DEVIATION 12.3 • n=4 Participants	70.8 Years STANDARD_DEVIATION 11.2 • n=21 Participants	64.7 Years STANDARD_DEVIATION 10.3 • n=8 Participants	65.0 Years STANDARD_DEVIATION 10.7 • n=8 Participants	67.3 Years STANDARD_DEVIATION 8.8 • n=24 Participants	63.9 Years STANDARD_DEVIATION 9.3 • n=42 Participants	63.8 Years STANDARD_DEVIATION 9.9 • n=42 Participants	60.5 Years STANDARD_DEVIATION 8.3 • n=42 Participants	60.9 Years STANDARD_DEVIATION 8.9 • n=42 Participants	71.9 Years STANDARD_DEVIATION 8.5 • n=36 Participants	63.4 Years STANDARD_DEVIATION 12.2 • n=36 Participants	61.0 Years STANDARD_DEVIATION 1.4 • n=24 Participants	66.0 Years STANDARD_DEVIATION 2.8 • n=135 Participants	56.0 Years STANDARD_DEVIATION 2.8 • n=136 Participants	77.5 Years STANDARD_DEVIATION 6.4 • n=44 Participants	64.7 Years STANDARD_DEVIATION 10.5 • n=667 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	8 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	7 Participants n=8 Participants	4 Participants n=24 Participants	5 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	0 Participants n=36 Participants	7 Participants n=36 Participants	0 Participants n=24 Participants	1 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	46 Participants n=667 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	12 Participants n=8 Participants	9 Participants n=8 Participants	12 Participants n=24 Participants	14 Participants n=42 Participants	11 Participants n=42 Participants	15 Participants n=42 Participants	18 Participants n=42 Participants	13 Participants n=36 Participants	23 Participants n=36 Participants	2 Participants n=24 Participants	1 Participants n=135 Participants	2 Participants n=136 Participants	2 Participants n=44 Participants	157 Participants n=667 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	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	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	1 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	3 Participants n=667 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	2 Participants n=7 Participants	13 Participants n=5 Participants	7 Participants n=4 Participants	5 Participants n=21 Participants	12 Participants n=8 Participants	15 Participants n=8 Participants	13 Participants n=24 Participants	18 Participants n=42 Participants	14 Participants n=42 Participants	14 Participants n=42 Participants	16 Participants n=42 Participants	12 Participants n=36 Participants	27 Participants n=36 Participants	2 Participants n=24 Participants	1 Participants n=135 Participants	2 Participants n=136 Participants	2 Participants n=44 Participants	185 Participants n=667 Participants
Ethnicity (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	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	1 Participants n=36 Participants	3 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	15 Participants n=667 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	8 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	9 Participants n=42 Participants	4 Participants n=42 Participants	0 Participants n=36 Participants	3 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	41 Participants n=667 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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	5 Participants n=667 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants	6 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	14 Participants n=8 Participants	13 Participants n=24 Participants	14 Participants n=42 Participants	11 Participants n=42 Participants	5 Participants n=42 Participants	12 Participants n=42 Participants	10 Participants n=36 Participants	25 Participants n=36 Participants	2 Participants n=24 Participants	2 Participants n=135 Participants	2 Participants n=136 Participants	2 Participants n=44 Participants	140 Participants n=667 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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants	0 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants
Race (NIH/OMB) Unknown or Not Reported	1 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	2 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	5 Participants n=42 Participants	2 Participants n=36 Participants	2 Participants n=36 Participants	0 Participants n=24 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	17 Participants n=667 Participants

PRIMARY outcome

Timeframe: From the first dose of study treatment until the first documented CR or PR or new anticancer therapies or death, whichever occurred first (maximum up to 8.3 months)

Population: The full analysis set (FAS) included all participants who received any amount of study drug.

Confirmed ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as more than or equal to (>=) 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have at least 2 post-baseline response assessment (initial response and confirmation scan) were counted as non-responders.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=10 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=13 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=7 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=5 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: Confirmed Objective Response Rate (ORR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)	—	—	—	10 Percentage of participants Interval 0.3 to 44.5	0 Percentage of participants Interval 0.0 to 84.2	8 Percentage of participants Interval 0.2 to 36.0	14 Percentage of participants Interval 0.4 to 57.9	20 Percentage of participants Interval 0.5 to 71.6	8 Percentage of participants Interval 0.2 to 38.5	—	—	—

PRIMARY outcome

Timeframe: From the first dose of study treatment until the first documented CR or PR or new anticancer therapies or death, whichever occurred first (maximum up to 34.7 months for 1.25 mg/kg and 5.7 months for 1 mg/kg dose level)

Population: The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Confirmed ORR was defined as the percentage of participants with a confirmed CR or PR per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR was defined as >= 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not have at least 2 post-baseline response assessment (initial response and confirmation scan) were counted as non-responders.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=2 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg n=2 Participants Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=16 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=16 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=19 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=14 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=17 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=21 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg n=13 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=30 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Confirmed ORR as Determined by Investigator According to RECIST v1.1	0 Percentage of participants Interval 0.0 to 84.2	0 Percentage of participants Interval 0.0 to 84.2	50 Percentage of participants Interval 1.3 to 98.7	6 Percentage of participants Interval 0.2 to 30.2	13 Percentage of participants Interval 1.6 to 38.3	11 Percentage of participants Interval 1.3 to 33.1	0 Percentage of participants Interval 0.0 to 23.2	18 Percentage of participants Interval 3.8 to 43.4	14 Percentage of participants Interval 3.0 to 36.3	0 Percentage of participants Interval 0.0 to 24.7	20 Percentage of participants Interval 7.7 to 38.6	0 Percentage of participants Interval 0.0 to 84.2

PRIMARY outcome

Timeframe: From the first dose of study treatment up to the date of last response assessment (maximum up to 13.5 months)

Population: The FAS included all participants who received any amount of study drug. As prespecified in protocol, this outcome measure was planned to be analyzed only in the Part B: Cohort 7, LV 1.25 mg/kg arm. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Confirmed PSA response rate was defined as the percentage of participants with a reduction from baseline PSA level of at least 50%, measured twice >= 3 weeks apart. PSA progression was defined as per PCWG3 criteria- a) if a participant presented first a decline from baseline, progression was defined as the first PSA increase that was >=25% and >=2 nanograms per milliliter (ng/mL) above the nadir, and which was confirmed by a consecutive second value >=3 weeks later that fulfilled the same criteria (that is, a confirmed rising trend); b) if a participant did not present a decline from baseline, progression was defined as the first PSA increase that was >=25% and >=2 ng/mL increased from baseline beyond 12 weeks.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=13 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Confirmed Prostate-Specific Antigen (PSA) Response Rate as Determined by Investigator According to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) Criteria, for Prostate Cancer	—	—	—	23 Percentage of participants Interval 5.0 to 53.8	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months)

Population: The safety analysis set included all participants who received any amount of study drug.

An adverse event (AE) was any untoward medical occurrence in a participant/ clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. AEs included both SAEs ad all non-SAEs. TEAEs were defined as newly occurring (not present at baseline)/worsening after first dose of study treatment. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity & may cause congenital anomaly/birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=10 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=13 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=7 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=5 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and >= Grade 3 TEAE TESAEs	—	—	—	5 Participants	1 Participants	7 Participants	2 Participants	3 Participants	3 Participants	—	—	—
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and >= Grade 3 TEAE TEAEs (>= Grade 3)	—	—	—	7 Participants	1 Participants	9 Participants	4 Participants	4 Participants	6 Participants	—	—	—
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and >= Grade 3 TEAE TEAEs	—	—	—	10 Participants	2 Participants	13 Participants	7 Participants	5 Participants	12 Participants	—	—	—
Part A: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Treatment Related TEAEs and >= Grade 3 TEAE Treatment Related TEAEs	—	—	—	9 Participants	2 Participants	11 Participants	7 Participants	5 Participants	11 Participants	—	—	—

SECONDARY outcome

Timeframe: From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months)

Population: The safety analysis set included all participants who received any amount of study drug.

An AE was any untoward medical occurrence in a participant, or a clinical investigational participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. AEs included both SAEs ad all non-SAEs. TEAEs were defined as newly occurring (not present at baseline) or worsening after first dose of study treatment. TESAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent or significant disability or incapacity and may cause congenital anomaly or birth defect. Treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI-CTCAE v4.03 (grade 1= mild, grade 2= moderate, grade 3= severe and grade 4= life-threatening).

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=2 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg n=2 Participants Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=16 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=16 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=19 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=14 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=17 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=21 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg n=13 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=30 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >= Grade 3 TEAE TEAEs	2 Participants	2 Participants	2 Participants	15 Participants	16 Participants	19 Participants	14 Participants	17 Participants	21 Participants	13 Participants	30 Participants	2 Participants
Part B: Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >= Grade 3 TEAE TESAEs	2 Participants	1 Participants	0 Participants	6 Participants	5 Participants	9 Participants	8 Participants	9 Participants	12 Participants	4 Participants	11 Participants	1 Participants
Part B: Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >= Grade 3 TEAE Treatment Related TEAEs	2 Participants	2 Participants	2 Participants	13 Participants	16 Participants	18 Participants	12 Participants	17 Participants	19 Participants	12 Participants	28 Participants	2 Participants
Part B: Number of Participants With TEAEs, TESAEs, Treatment Related TEAEs and >= Grade 3 TEAE TEAEs (>= Grade 3)	2 Participants	1 Participants	0 Participants	12 Participants	11 Participants	14 Participants	11 Participants	13 Participants	17 Participants	8 Participants	17 Participants	1 Participants

SECONDARY outcome

Timeframe: From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 4.1 months)

Population: The FAS included all participants who received any amount of study drug.

DCR was defined as percentage of participants who achieved confirmed and unconfirmed CR or PR per RECIST v1.1 or met stable disease (SD) criteria at least once after start of study treatment at minimum interval of 5 weeks. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as >= 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference smallest sum diameters while on study. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions was also considered progression.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=10 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=13 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=7 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=5 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: Confirmed Investigator Determined Disease Control Rate (DCR) According to RECIST v1.1	—	—	—	40 Percentage of participants Interval 12.2 to 73.8	50 Percentage of participants Interval 1.3 to 98.7	46 Percentage of participants Interval 19.2 to 74.9	57 Percentage of participants Interval 18.4 to 90.1	60 Percentage of participants Interval 14.7 to 94.7	33 Percentage of participants Interval 9.9 to 65.1	—	—	—

SECONDARY outcome

Timeframe: From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 5.5 months for 1.25 mg/kg and 1.5 months for 1 mg/kg dose level)

Population: The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

DCR was defined as percentage of participants who achieved confirmed and unconfirmed CR or PR per RECIST v1.1 or met SD criteria at least once after start of study treatment at a minimum interval of 5 weeks. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR was defined as >= 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: At least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included 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 0.5 centimeter (cm). Appearance of one or more new lesions was also considered progression.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=2 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg n=2 Participants Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=16 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=16 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=19 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=14 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=17 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=21 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg n=13 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=30 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Confirmed Investigator Determined DCR According to RECIST v1.1	50 Percentage of participants Interval 1.3 to 98.7	0 Percentage of participants Interval 0.0 to 84.2	100 Percentage of participants Interval 15.8 to 100.0	19 Percentage of participants Interval 4.0 to 45.6	50 Percentage of participants Interval 24.7 to 75.3	58 Percentage of participants Interval 33.5 to 79.7	64 Percentage of participants Interval 35.1 to 87.2	59 Percentage of participants Interval 32.9 to 81.6	52 Percentage of participants Interval 29.8 to 74.3	62 Percentage of participants Interval 31.6 to 86.1	77 Percentage of participants Interval 57.7 to 90.1	50 Percentage of participants Interval 1.3 to 98.7

SECONDARY outcome

Timeframe: From the first documentation of CR or PR to PD or death or censoring whichever occurred first (maximum up to 5.7 months)

Population: The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. No participant had CR or PR in Part A: Cohort 2, LV 2.5 mg/kg arm.

DOR:time from 1st documentation of OR(confirmed CR/PR per RECIST Version 1.1) to 1st documentation of PD/death due to any cause,whichever occurred first.CR:disappearance of all target lesions.Any pathological lymph nodes must have reduction in short axis to <10 mm.PR:>=30 % decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Participants do not have PD and are still on study at time of analysis/are removed from study prior to documentation of PD were censored at last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.PD:at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study.In addition to relative increase of 20%, sum must demonstrate absolute increase of 0.5 cm.Appearance of one/more new lesions was considered progression. Kaplan-Meier method was used.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=1 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=1 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=1 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=1 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=1 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: Confirmed Investigator Determined Duration of Response (DOR) According to RECIST v1.1	—	—	—	5.7 Months There was only 1 participant evaluable, hence lower and upper limit of the 95% confidence interval could not be estimated.	—	5.5 Months There was only 1 participant evaluable, hence lower and upper limit of the 95% confidence interval could not be estimated.	3.7 Months There was only 1 participant evaluable, hence lower and upper limit of the 95% confidence interval could not be estimated.	2.7 Months There was only 1 participant evaluable, hence lower and upper limit of the 95% confidence interval could not be estimated.	NA Months No participant had an event of interest; hence results could not be estimated.	—	—	—

SECONDARY outcome

Timeframe: From the first documentation of CR or PR to PD or death or censoring whichever occurred first (maximum up to 32.0 months for 1.25 mg/kg and 4.2 months for 1 mg/kg dose level)

Population: The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. No participant had CR or PR in Part B: Cohort 4, LV 1.25 mg/kg arm, Part B: Cohort 7, LV 1.25 mg/kg arm, Part B: Cohort 1, LV 1.0 mg/kg arm, Part B: Cohort 3, LV 1.0 mg/kg arm and Part B: Cohort 4, LV 1.0 mg/kg arm.

DOR:time from 1st documentation of OR(confirmed CR/PR per RECIST Version 1.1) to 1st documentation of PD/death due to any cause,whichever occurred first.CR:disappearance of all target lesions.Any pathological lymph nodes must have reduction in short axis to <10 mm.PR:>=30 % decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Participants do not have PD and are still on study at time of analysis/are removed from study prior to documentation of PD were censored at last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment.PD:at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study.In addition to relative increase of 20%, sum must demonstrate absolute increase of 0.5 cm.Appearance of one/more new lesions was considered progression. Kaplan-Meier method was used.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg n=1 Participants Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=1 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=3 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=3 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=6 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Confirmed Investigator Determined DOR According to RECIST v1.1	—	—	4.2 Months There was only 1 participant evaluable, hence lower and upper limit of the 95% confidence interval could not be estimated.	NA Months No participant had an event of interest; hence data could not be reported.	7.5 Months Interval 5.78 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	NA Months Interval 16.59 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	—	NA Months Interval 3.06 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	3.9 Months Interval 2.6 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	—	8.3 Months Interval 5.62 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	—

SECONDARY outcome

Timeframe: From the first documentation of CR or PR to PD or death or censoring whichever occurred first (maximum up to 3 months)

Population: The FAS included all participants who received any amount of study drug. As prespecified in protocol, this outcome measure was planned to be analyzed only in the Part B: Cohort 7, LV 1.25 mg/kg arm. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

PSA-DOR was defined as the time from the first documentation of PSA response (subsequently confirmed at least 3 weeks apart) to the first documentation of PSA progression or death due to any cause, whichever occurred first. Confirmed PSA response rate was defined as the percentage of participants with a reduction from baseline PSA level of at least 50%, measured twice >= 3 weeks apart. Participants who do not have PD and are still on study at the time of an analysis or who are removed from the study prior to documentation of PD was censored at the date of last disease assessment documenting absence of PD. Participants who started a new anticancer treatment prior to documentation of PD were censored at the date of last disease assessment prior to the start of new treatment. The confidence interval (CI) was calculated using the complementary log-log transformation method.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=3 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Confirmed Investigator Determined PSA-DOR, for Prostate Cancer	—	—	—	3.0 Months Interval 1.9 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study treatment to the date of PD or clinical PD or censoring whichever occurred first (maximum up to 8.3 months)

Population: The FAS included all participants who received any amount of study drug.

PFS: time from start of study treatment to the first documentation of PD by RECIST v1.1 or clinical PD. Participants who do not have PD and are still on study at the time of an analysis or who are removed from the study prior to documentation of PD were censored at the date of last disease assessment documenting absence of PD. Participants who started a new anticancer treatment prior to documentation of PD were censored at the date of last disease assessment prior to the start of new treatment. PD: At least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included 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 0.5 cm. Appearance of one or more new lesions was also considered progression. Median was estimated using the Kaplan-Meier method and the CI was calculated using the complementary log-log transformation method.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=10 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=13 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=7 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=5 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: Confirmed Investigator Determined Progression Free Survival (PFS) According to RECIST v1.1	—	—	—	1.4 Months Interval 0.53 to 2.69	1.5 Months Interval 1.25 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	2.5 Months Interval 0.46 to 4.17	2.3 Months Interval 0.33 to 4.86	2.9 Months Interval 0.59 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	1.4 Months Interval 1.31 to 4.17	—	—	—

SECONDARY outcome

Timeframe: From first dose of study treatment to the date of PD or clinical PD or censoring whichever occurred first (maximum up to 34.7 months for 1.25 mg/kg and 5.7 months for 1 mg/kg dose level)

Population: The FAS included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

PFS: time from start of study treatment to the first documentation of PD by RECIST v1.1 or clinical PD. Participants who do not have PD and are still on study at the time of an analysis or who are removed from the study prior to documentation of PD were censored at the date of last disease assessment documenting absence of PD. Participants who started a new anticancer treatment prior to documentation of PD were censored at the date of last disease assessment prior to the start of new treatment. PD: At least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included 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 0.5 cm. Appearance of one or more new lesions was also considered progression. Median was estimated using the Kaplan-Meier method and the CI was calculated using the complementary log-log transformation method.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=2 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg n=2 Participants Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=16 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=16 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=19 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=14 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=17 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=21 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg n=13 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=30 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Confirmed Investigator Determined PFS According to RECIST v1.1	NA Months Only one participant had event, hence median and CI were not reported. The individual participant data was 1.3 months.	1.5 Months Interval 1.35 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	4.2 Months Interval 2.76 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	1.4 Months Interval 1.18 to 2.04	1.8 Months Interval 1.12 to 5.72	2.4 Months Interval 1.31 to 2.96	2.7 Months Interval 1.18 to 2.86	2.8 Months Interval 1.38 to 3.32	2.3 Months Interval 1.25 to 2.73	4.9 Months Interval 2.1 to 5.65	4.2 Months Interval 2.5 to 6.97	1.9 Months Interval 1.02 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.

SECONDARY outcome

Timeframe: From first dose of study treatment to the date of PD or clinical PD or censoring whichever occurred first (maximum up to 5.7 months)

Population: The FAS included all participants who received any amount of study drug. As prespecified in protocol, this outcome measure was planned to be analyzed only in the Part B: Cohort 7, LV 1.25 mg/kg arm. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

PSA-PFS: time from start of study treatment to first documentation of PSA progression or death due to any cause, whichever occurred first. Participants who do not have PD and are still on study at time of analysis or who are removed from study prior to documentation of PD was censored at date of last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at date of last disease assessment prior to the start of new treatment. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that is smallest on study). In addition to relative increase of 20%, sum must also demonstrate absolute increase of at least 0.5 cm. Appearance of one or more new lesions was also considered progression. Median was estimated using Kaplan-Meier method and CI was calculated using the complementary log-log transformation method.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=9 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Confirmed Investigator Determined PSA-PFS, for Prostate Cancer	—	—	—	3.7 Months Interval 2.8 to 5.1	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of study treatment to the date of death or censoring whichever occurred first (maximum up to 27.5 months)

Population: The FAS included all participants who received any amount of study drug.

OS was defined as the time from the start of study treatment to date of death due to any cause. Participants who do not have PD and are still on study at the time of an analysis or who are removed from the study prior to documentation of PD was censored at the date of last disease assessment documenting absence of PD. Participants who started a new anticancer treatment prior to documentation of PD were censored at the date of last disease assessment prior to the start of new treatment. Median was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=10 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=13 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=7 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=5 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: Overall Survival (OS)	—	—	—	6.1 Months Interval 1.38 to 15.84	2.5 Months Interval 1.74 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	6.5 Months Interval 2.2 to 16.95	4.8 Months Interval 0.33 to 6.97	7.2 Months Interval 0.59 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	8.7 Months Interval 3.98 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	—	—	—

SECONDARY outcome

Timeframe: From first dose of study treatment to the date of death or censoring whichever occurred first (maximum up to 37.5 months for 1.25 mg/kg and 20.9 months for 1 mg/kg dose level)

Population: The FAS included all participants who received any amount of study drug.

OS was defined as the time from the start of study treatment to date of death due to any cause. Participants who do not have PD and are still on study at the time of an analysis or who are removed from the study prior to documentation of PD was censored at the date of last disease assessment documenting absence of PD. Participants who started a new anticancer treatment prior to documentation of PD were censored at the date of last disease assessment prior to the start of new treatment. Median was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=2 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg n=2 Participants Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=16 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=16 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=19 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=14 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=17 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=21 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg n=13 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=30 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Overall Survival	NA Months Interval 1.71 to Insufficient number of participants with events to calculate the median and upper limit of the 95% confidence interval.	5.6 Months Interval 1.64 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	14.2 Months Interval 8.34 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	4.7 Months Interval 3.45 to 8.74	9.0 Months Interval 4.53 to 12.68	9.3 Months Interval 2.92 to 20.14	5.2 Months Interval 3.42 to 18.33	12.7 Months Interval 4.17 to 15.28	3.8 Months Interval 1.77 to 8.61	10.1 Months Interval 6.47 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.	11.5 Months Interval 9.26 to 15.41	11.1 Months Interval 1.22 to Insufficient number of participants with events to calculate the upper limit of the 95% confidence interval.

SECONDARY outcome

Timeframe: AUC21 is reported on Day 21 using PK concentrations assessed at Pre-dose, end of infusion, 2 hour, 4 hour, 48 hour, 168 hour and 336 hour post dose of Cycle 1 (each cycle = 21 days, LV administered on Day 1 of cycle)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Area under the observed concentration-time curve from the time of dosing to Day 21 of LV was calculated by noncompartmental analysis.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=10 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=11 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=6 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=5 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: Area Under the Serum Concentration Time Curve Between Days 0 to 21 (AUC21) of Ladiratuzumab Vedotin	—	—	—	142.5 Day*micrograms per milliliter Geometric Coefficient of Variation 18.9	175.6 Day*micrograms per milliliter Geometric Coefficient of Variation 16.5	145.3 Day*micrograms per milliliter Geometric Coefficient of Variation 35.1	146.6 Day*micrograms per milliliter Geometric Coefficient of Variation 28.3	123.2 Day*micrograms per milliliter Geometric Coefficient of Variation 21.7	132.0 Day*micrograms per milliliter Geometric Coefficient of Variation 26.0	—	—	—

SECONDARY outcome

Timeframe: Cmax during Day 1 to 21 post LV administration on Day 1 was reported using PK concentration assessed at Pre-dose, end of infusion, 2 hour, 4 hour, 48 hour, 168 hour and 336 hour post-dose of LV administration on Day 1 (each cycle = 21 days)

Population: The safety analysis set included all participants who received any amount of study drug.

Cmax according to ADC pharmacokinetic parameters was reported.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=10 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=13 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=7 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=5 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: Maximum Serum Concentration (Cmax) According to Antibody-Drug Conjugate (ADC) Pharmacokinetic Parameters	—	—	—	50.4 Micrograms per milliliter Geometric Coefficient of Variation 31.2	58.6 Micrograms per milliliter Geometric Coefficient of Variation 1.0	55.8 Micrograms per milliliter Geometric Coefficient of Variation 29.6	52.3 Micrograms per milliliter Geometric Coefficient of Variation 23.6	39.6 Micrograms per milliliter Geometric Coefficient of Variation 14.7	55.2 Micrograms per milliliter Geometric Coefficient of Variation 64.9	—	—	—

SECONDARY outcome

Timeframe: AUC21 is reported on Day 21 using PK concentrations assessed at Pre-dose, end of infusion, 2 hour, 4 hour, 48 hour, 168 hour and 336 hour post dose of Cycle 1 (each cycle = 21 days, LV administered on Day 1 of cycle)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Area under the observed concentration-time curve from the time of dosing to Day 21 of TAB was calculated by noncompartmental analysis.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=10 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=10 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=6 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=5 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=10 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: AUC21 of Total Antibody (TAB)	—	—	—	302.4 Day*micrograms per milliliter Geometric Coefficient of Variation 19.7	328.5 Day*micrograms per milliliter Geometric Coefficient of Variation 17.8	280.3 Day*micrograms per milliliter Geometric Coefficient of Variation 34.1	292.3 Day*micrograms per milliliter Geometric Coefficient of Variation 28.2	219.8 Day*micrograms per milliliter Geometric Coefficient of Variation 28.5	258.9 Day*micrograms per milliliter Geometric Coefficient of Variation 31.6	—	—	—

SECONDARY outcome

Timeframe: Cmax during Day 1 to 21 post LV administration on Day 1 was reported using PK concentration assessed at Pre-dose, end of infusion, 2 hour, 4 hour, 48 hour, 168 hour and 336 hour post-dose of LV administration on Day 1 (each cycle = 21 days)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Cmax according to TAB pharmacokinetic parameters was reported.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=9 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=11 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=7 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=5 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=10 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: Cmax According to TAB Pharmacokinetic Parameters	—	—	—	61.6 Micrograms per milliliter Geometric Coefficient of Variation 23.7	66.1 Micrograms per milliliter Geometric Coefficient of Variation 20.8	68.2 Micrograms per milliliter Geometric Coefficient of Variation 30.5	61.4 Micrograms per milliliter Geometric Coefficient of Variation 16.1	50.7 Micrograms per milliliter Geometric Coefficient of Variation 38.3	57.2 Micrograms per milliliter Geometric Coefficient of Variation 24.1	—	—	—

SECONDARY outcome

Timeframe: AUC21 is reported on Day 21 using PK concentrations assessed at Pre-dose, end of infusion, 2 hour, 4 hour, 48 hour, 168 hour and 336 hour post dose of Cycle 1 (each cycle = 21 days, LV administered on Day 1 of cycle)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Area under the observed concentration-time curve from the time of dosing to Day 21 of MMAE was calculated by noncompartmental analysis.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=2 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=1 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=7 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=3 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=2 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=7 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: AUC21 of Monomethyl Auristatin E (MMAE)	—	—	—	34.1 Day*nanogram per milliliter Geometric Coefficient of Variation 21.1	50.5 Day*nanogram per milliliter Geometric Coefficient of Variation NA Insufficient number of participants to calculate the geometric coefficient of variation.	62.9 Day*nanogram per milliliter Geometric Coefficient of Variation 79.3	66.2 Day*nanogram per milliliter Geometric Coefficient of Variation 45.6	91.0 Day*nanogram per milliliter Geometric Coefficient of Variation 19.3	35.2 Day*nanogram per milliliter Geometric Coefficient of Variation 36.9	—	—	—

SECONDARY outcome

Timeframe: Cmax during Day 1 to 21 post LV administration on Day 1 was reported using PK concentration assessed at Pre-dose, end of infusion, 2 hour, 4 hour, 48 hour, 168 hour and 336 hour post-dose of LV administration on Day 1 (each cycle = 21 days)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Cmax according to MMAE pharmacokinetic parameters was reported.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=2 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=1 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=7 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=2 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=2 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=6 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: Cmax According to MMAE Pharmacokinetic Parameters	—	—	—	2.8 Nanogram per milliliter Geometric Coefficient of Variation 15.7	5.7 Nanogram per milliliter Geometric Coefficient of Variation NA Insufficient number of participants to calculate the geometric coefficient of variation.	6.4 Nanogram per milliliter Geometric Coefficient of Variation 83.1	6.3 Nanogram per milliliter Geometric Coefficient of Variation 10.6	11.3 Nanogram per milliliter Geometric Coefficient of Variation 12.6	3.6 Nanogram per milliliter Geometric Coefficient of Variation 41.8	—	—	—

SECONDARY outcome

Timeframe: AUC7 is reported at Day 7 using PK concentration assessed at Pre-dose, end of infusion, 2hr, 4hr, 48hr post-dose of LV administration on Day 1; pre-dose PK concentration on Day 8 in Cycle 1 (each cycle=21 days, LV administered on Day 1, 8 and 15 of cycle)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. There were insufficient samples to provide pharmacokinetic (PK) estimates for analytes in Part B: Cohort 6, LV 1.0 mg/kg arm.

Area under the observed concentration-time curve from the time of dosing to Day 7 of ADC was calculated by noncompartmental analysis.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=1 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=14 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=11 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=18 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=9 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=14 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg n=11 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=25 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Area Under the Concentration Time Curve Between Day 0 to 7 (AUC7) of ADC	52.0 Day*micrograms per milliliter Geometric Coefficient of Variation 0.1	44.8 Day*micrograms per milliliter Geometric Coefficient of Variation NA Insufficient number of participants to calculate the geometric coefficient of variation.	—	57.3 Day*micrograms per milliliter Geometric Coefficient of Variation 23.2	51.7 Day*micrograms per milliliter Geometric Coefficient of Variation 16.9	59.5 Day*micrograms per milliliter Geometric Coefficient of Variation 29.7	60.6 Day*micrograms per milliliter Geometric Coefficient of Variation 36.7	43.3 Day*micrograms per milliliter Geometric Coefficient of Variation 12.6	50.7 Day*micrograms per milliliter Geometric Coefficient of Variation 27.2	66.0 Day*micrograms per milliliter Geometric Coefficient of Variation 42.8	46.8 Day*micrograms per milliliter Geometric Coefficient of Variation 25.0	42.1 Day*micrograms per milliliter Geometric Coefficient of Variation 0.5

SECONDARY outcome

Timeframe: Cmax during Day 1 to 7 post LV administration on Day 1 was reported using PK concentration assessed at Pre-dose, end of infusion, 2 hr, 4 hr, 48 hr post-dose of LV administration on Day 1 (each cycle = 21 days, LV administered on Day 1, 8 and 15 of cycle)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. There were insufficient samples to provide PK estimates for analytes in Part B: Cohort 6, LV 1.0 mg/kg arm.

Cmax according to ADC pharmacokinetic parameters was reported.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=2 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=16 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=14 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=19 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=14 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=17 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=18 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg n=12 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=27 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Cmax According to ADC Pharmacokinetic Parameters	24.3 Micrograms per milliliter Geometric Coefficient of Variation 10.2	24.1 Micrograms per milliliter Geometric Coefficient of Variation 6.2	—	35.3 Micrograms per milliliter Geometric Coefficient of Variation 35.0	27.8 Micrograms per milliliter Geometric Coefficient of Variation 19.7	30.9 Micrograms per milliliter Geometric Coefficient of Variation 19.2	28.7 Micrograms per milliliter Geometric Coefficient of Variation 28.6	25.0 Micrograms per milliliter Geometric Coefficient of Variation 28.8	28.0 Micrograms per milliliter Geometric Coefficient of Variation 17.2	30.5 Micrograms per milliliter Geometric Coefficient of Variation 15.1	25.4 Micrograms per milliliter Geometric Coefficient of Variation 21.9	29.5 Micrograms per milliliter Geometric Coefficient of Variation 20.3

SECONDARY outcome

Timeframe: AUC7 is reported at Day 7 using PK concentration assessed at Pre-dose, end of infusion, 2hr, 4hr, 48hr post-dose of LV administration on Day 1; pre-dose PK concentration on Day 8 in Cycle 1 (each cycle=21 days, LV administered on Day 1, 8 and 15 of cycle)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. There were insufficient samples to provide PK estimates for analytes in Part B: Cohort 6, LV 1.0 mg/kg arm.

Area under the observed concentration-time curve from the time of dosing to Day 7of TAB was calculated by noncompartmental analysis.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=1 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=14 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=11 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=18 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=9 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=14 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg n=11 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=25 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: AUC7 of TAB	88.6 Day*micrograms per milliliter Geometric Coefficient of Variation 11.1	71.4 Day*micrograms per milliliter Geometric Coefficient of Variation NA Insufficient number of participants to calculate the geometric coefficient of variation.	—	101.1 Day*micrograms per milliliter Geometric Coefficient of Variation 29.4	92.7 Day*micrograms per milliliter Geometric Coefficient of Variation 18.7	106.9 Day*micrograms per milliliter Geometric Coefficient of Variation 29.8	91.2 Day*micrograms per milliliter Geometric Coefficient of Variation 30.9	73.9 Day*micrograms per milliliter Geometric Coefficient of Variation 20.7	85.7 Day*micrograms per milliliter Geometric Coefficient of Variation 26.0	106.5 Day*micrograms per milliliter Geometric Coefficient of Variation 28.2	74.7 Day*micrograms per milliliter Geometric Coefficient of Variation 26.3	76.6 Day*micrograms per milliliter Geometric Coefficient of Variation 22.6

SECONDARY outcome

Timeframe: Cmax during Day 1 to 7 post LV administration on Day 1 was reported using PK concentration assessed at Pre-dose, end of infusion, 2 hr, 4 hr, 48 hr post-dose of LV administration on Day 1 (each cycle = 21 days, LV administered on Day 1, 8 and 15 of cycle)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. There were insufficient samples to provide PK estimates for analytes in Part B: Cohort 6, LV 1.0 mg/kg arm.

Cmax according to TAB pharmacokinetic parameters was reported.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=2 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=16 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=14 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=19 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=14 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=17 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=17 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg n=12 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=29 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Cmax According to TAB Pharmacokinetic Parameters	30.6 Micrograms per milliliter Geometric Coefficient of Variation 14.8	27.9 Micrograms per milliliter Geometric Coefficient of Variation 2.0	—	38.3 Micrograms per milliliter Geometric Coefficient of Variation 17.9	31.6 Micrograms per milliliter Geometric Coefficient of Variation 16.6	36.8 Micrograms per milliliter Geometric Coefficient of Variation 21.8	32.1 Micrograms per milliliter Geometric Coefficient of Variation 26.2	27.4 Micrograms per milliliter Geometric Coefficient of Variation 28.9	31.3 Micrograms per milliliter Geometric Coefficient of Variation 19.7	32.6 Micrograms per milliliter Geometric Coefficient of Variation 25.9	32.5 Micrograms per milliliter Geometric Coefficient of Variation 73.8	26.8 Micrograms per milliliter Geometric Coefficient of Variation 15.6

SECONDARY outcome

Timeframe: AUC7 is reported at Day 7 using PK concentration assessed at Pre-dose, end of infusion, 2hr, 4hr, 48hr post-dose of LV administration on Day 1; pre-dose PK concentration on Day 8 in Cycle 1 (each cycle=21 days, LV administered on Day 1, 8 and 15 of cycle)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. There were insufficient samples to provide PK estimates for analytes in Part B: Cohort 6, LV 1.0 mg/kg arm.

Area under the observed concentration-time curve from the time of dosing to Day 7 of MMAE was calculated by noncompartmental analysis.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=1 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=14 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=11 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=18 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=9 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=14 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg n=11 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=25 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: AUC7 OF MMAE	12.4 Day*micrograms per milliliter Geometric Coefficient of Variation 25.9	8.5 Day*micrograms per milliliter Geometric Coefficient of Variation NA Insufficient number of participants to calculate the geometric coefficient of variation.	—	14.6 Day*micrograms per milliliter Geometric Coefficient of Variation 63.1	16.5 Day*micrograms per milliliter Geometric Coefficient of Variation 55.6	11.9 Day*micrograms per milliliter Geometric Coefficient of Variation 51.5	15.6 Day*micrograms per milliliter Geometric Coefficient of Variation 51.0	17.3 Day*micrograms per milliliter Geometric Coefficient of Variation 67.6	13.7 Day*micrograms per milliliter Geometric Coefficient of Variation 83.0	10.7 Day*micrograms per milliliter Geometric Coefficient of Variation 57.3	13.8 Day*micrograms per milliliter Geometric Coefficient of Variation 45.2	10.8 Day*micrograms per milliliter Geometric Coefficient of Variation 64.1

SECONDARY outcome

Timeframe: Cmax during Day 1 to 7 post LV administration on Day 1 was reported using PK concentration assessed at Pre-dose, end of infusion, 2 hr, 4 hr, 48 hr post-dose of LV administration on Day 1 (each cycle= 21 days, LV administered on Day 1, 8 and 15 of cycle)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. There were insufficient samples to provide PK estimates for analytes in Part B: Cohort 6, LV 1.0 mg/kg arm.

Cmax according to MMAE pharmacokinetic parameters was reported.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=1 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=10 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=4 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=8 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=8 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=15 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=11 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg n=8 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=16 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=1 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Cmax According to MMAE Pharmacokinetic Parameters	—	1.7 Nanograms per milliliter Geometric Coefficient of Variation NA Insufficient number of participants to calculate the geometric coefficient of variation.	—	2.8 Nanograms per milliliter Geometric Coefficient of Variation 60.7	4.5 Nanograms per milliliter Geometric Coefficient of Variation 50.4	2.6 Nanograms per milliliter Geometric Coefficient of Variation 59.1	2.7 Nanograms per milliliter Geometric Coefficient of Variation 39.9	3.3 Nanograms per milliliter Geometric Coefficient of Variation 65.8	2.9 Nanograms per milliliter Geometric Coefficient of Variation 114.9	1.7 Nanograms per milliliter Geometric Coefficient of Variation 28.9	2.4 Nanograms per milliliter Geometric Coefficient of Variation 52.7	1.4 Nanograms per milliliter Geometric Coefficient of Variation NA Insufficient number of participants to calculate the geometric coefficient of variation.

SECONDARY outcome

Timeframe: From first ATA draw to last ATA draw (maximum up to 8.8 months)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=9 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=12 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=6 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=4 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part A: Number of Participants With Positive Post-Baseline Antitherapeutic Antibody (ATA) Incidence Baseline Negative and Negative post-baseline	—	—	—	8 Participants	2 Participants	9 Participants	4 Participants	4 Participants	10 Participants	—	—	—
Part A: Number of Participants With Positive Post-Baseline Antitherapeutic Antibody (ATA) Incidence Baseline Positive and Positive post-baseline	—	—	—	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Part A: Number of Participants With Positive Post-Baseline Antitherapeutic Antibody (ATA) Incidence Baseline Negative and Positive post-baseline	—	—	—	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	—	—	—
Part A: Number of Participants With Positive Post-Baseline Antitherapeutic Antibody (ATA) Incidence Baseline Positive and Negative post-baseline	—	—	—	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants	—	—	—

SECONDARY outcome

Timeframe: From first ATA draw to last ATA draw (maximum up to 22.1 months for 1.25 mg/kg and 5.1 months for 1 mg/kg)

Population: The safety analysis set included all participants who received any amount of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

A positive baseline ATA result was considered positive post-baseline if the post-baseline ATA titer result was at least four times higher than the baseline result.

Outcome measures

Measure	Part B: Cohort 3, LV 1.0 mg/kg n=2 Participants Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=1 Participants Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg n=2 Participants Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part A: Cohort 1, LV 2.5 mg/kg n=12 Participants Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=13 Participants Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=19 Participants Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=12 Participants Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=14 Participants Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 Participants Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 7, LV 1.25 mg/kg n=10 Participants Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=29 Participants Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 Participants Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.
Part B: Number of Participants With Positive Post-Baseline ATA Incidence Baseline Negative and Negative post-baseline	0 Participants	1 Participants	2 Participants	10 Participants	11 Participants	13 Participants	12 Participants	11 Participants	10 Participants	9 Participants	24 Participants	2 Participants
Part B: Number of Participants With Positive Post-Baseline ATA Incidence Baseline Negative and Positive post-baseline	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants	4 Participants	0 Participants	2 Participants	1 Participants	1 Participants	4 Participants	0 Participants
Part B: Number of Participants With Positive Post-Baseline ATA Incidence Baseline Positive and Negative post-baseline	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Part B: Number of Participants With Positive Post-Baseline ATA Incidence Baseline Positive and Positive post-baseline	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Part A: Cohort 1, LV 2.5 mg/kg

Serious events: 5 serious events

Other events: 10 other events

Deaths: 9 deaths

Part A: Cohort 2, LV 2.5 mg/kg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Part A: Cohort 3, LV 2.5 mg/kg

Serious events: 7 serious events

Other events: 13 other events

Deaths: 10 deaths

Part A: Cohort 4, LV 2.5 mg/kg

Serious events: 2 serious events

Other events: 6 other events

Deaths: 7 deaths

Part A: Cohort 5, LV 2.5 mg/kg

Serious events: 3 serious events

Other events: 5 other events

Deaths: 4 deaths

Part A: Cohort 6, LV 2.5 mg/kg

Serious events: 3 serious events

Other events: 12 other events

Deaths: 5 deaths

Part B: Cohort 1, LV 1.25 mg/kg

Serious events: 6 serious events

Other events: 15 other events

Deaths: 13 deaths

Part B: Cohort 2, LV 1.25 mg/kg

Serious events: 5 serious events

Other events: 16 other events

Deaths: 13 deaths

Part B: Cohort 3, LV 1.25 mg/kg

Serious events: 9 serious events

Other events: 19 other events

Deaths: 14 deaths

Part B: Cohort 4, LV 1.25 mg/kg

Serious events: 8 serious events

Other events: 14 other events

Deaths: 12 deaths

Part B: Cohort 5, LV 1.25 mg/kg

Serious events: 9 serious events

Other events: 17 other events

Deaths: 12 deaths

Part B: Cohort 6, LV 1.25 mg/kg

Serious events: 12 serious events

Other events: 19 other events

Deaths: 13 deaths

Part B: Cohort 7, LV 1.25 mg/kg

Serious events: 4 serious events

Other events: 13 other events

Deaths: 7 deaths

Part B: Cohort 8, LV 1.25 mg/kg

Serious events: 11 serious events

Other events: 30 other events

Deaths: 16 deaths

Part B: Cohort 1, LV 1.0 mg/kg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Part B: Cohort 3, LV 1.0 mg/kg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Part B: Cohort 4, LV 1.0 mg/kg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

Part B: Cohort 6, LV 1.0 mg/kg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Measure	Part A: Cohort 1, LV 2.5 mg/kg n=10 participants at risk Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 participants at risk Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=13 participants at risk Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=7 participants at risk Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=5 participants at risk Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 participants at risk Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 1, LV 1.25 mg/kg n=16 participants at risk Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.	Part B: Cohort 2, LV 1.25 mg/kg n=16 participants at risk Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 3, LV 1.25 mg/kg n=19 participants at risk Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.25 mg/kg n=14 participants at risk Participants with HNSCC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 5, LV 1.25 mg/kg n=17 participants at risk Participants with esophageal-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.25 mg/kg n=21 participants at risk Participants with GEJ were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 7, LV 1.25 mg/kg n=13 participants at risk Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=30 participants at risk Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 participants at risk Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.	Part B: Cohort 3, LV 1.0 mg/kg n=2 participants at risk Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=2 participants at risk Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg n=2 participants at risk Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Blood and lymphatic system disorders Febrile neutropenia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Blood and lymphatic system disorders Leukocytosis	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Cardiac disorders Acute myocardial infarction	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Cardiac disorders Cardiac arrest	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Cardiac disorders Myocardial infarction	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Cardiac disorders Pericardial effusion	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Cardiac disorders Stress cardiomyopathy	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Congenital, familial and genetic disorders Laryngocele	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Endocrine disorders Adrenal insufficiency	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 3/21 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Colitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Constipation	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	9.5% 2/21 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Ileus	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Nausea	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Oesophageal fistula	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Oesophageal pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Asthenia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	25.0% 3/12 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	9.5% 2/21 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Complication associated with device	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Fatigue	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Multiple organ dysfunction syndrome	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Non-cardiac chest pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Oedema peripheral	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Pyrexia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Arthritis bacterial	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Biliary sepsis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Biliary tract infection	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Bronchitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Conjunctivitis bacterial	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Device related infection	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Infection	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Liver abscess	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Periorbital cellulitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Pneumonia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Pneumonia aspiration	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Sepsis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Staphylococcal infection	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Staphylococcal sepsis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Urinary tract infection	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Injury, poisoning and procedural complications Overdose	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Brain natriuretic peptide increased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Neutrophil count decreased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hyponatraemia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 2/10 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	28.6% 2/7 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Acute motor-sensory axonal neuropathy	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Demyelinating polyneuropathy	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Dizziness	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Encephalopathy	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Haemorrhage intracranial	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Metabolic encephalopathy	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Petit mal epilepsy	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Seizure	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Spinal cord compression	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Syncope	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Vocal cord paralysis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Psychiatric disorders Mental status changes	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Pharyngeal haemorrhage	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	11.8% 2/17 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Vascular disorders Hypotension	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.

Other adverse events

Measure	Part A: Cohort 1, LV 2.5 mg/kg n=10 participants at risk Participants with SCLC were administered ladiratuzumab vedotin (LV) 2.5 milligram per kilogram (mg/kg) as intravenous (IV) fusion on Day 1 of each 21-day cycle (q3wk).	Part A: Cohort 2, LV 2.5 mg/kg n=2 participants at risk Participants with NSCLC-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 3, LV 2.5 mg/kg n=13 participants at risk Participants with NSCLC-nonsquamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 4, LV 2.5 mg/kg n=7 participants at risk Participants with HNSCC were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 5, LV 2.5 mg/kg n=5 participants at risk Participants with esophageal-squamous were administered LV 2.5 mg/kg as IV fusion q3wk.	Part A: Cohort 6, LV 2.5 mg/kg n=12 participants at risk Participants with GEJ were administered LV 2.5 mg/kg as IV fusion q3wk.	Part B: Cohort 1, LV 1.25 mg/kg n=16 participants at risk Participants with SCLC were administered LV 1.25 mg/kg on Days 1, 8 and 15 of each 21-day cycle (q1wk) as a 30-minute IV infusion.	Part B: Cohort 2, LV 1.25 mg/kg n=16 participants at risk Participants with NSCLC-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 3, LV 1.25 mg/kg n=19 participants at risk Participants with NSCLC-nonsquamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.25 mg/kg n=14 participants at risk Participants with HNSCC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 5, LV 1.25 mg/kg n=17 participants at risk Participants with esophageal-squamous were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.25 mg/kg n=21 participants at risk Participants with GEJ were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 7, LV 1.25 mg/kg n=13 participants at risk Participants with CRPC were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 8, LV 1.25 mg/kg n=30 participants at risk Participants with melanoma were administered LV 1.25 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 1, LV 1.0 mg/kg n=2 participants at risk Participants with SCLC were administered LV 1.0 mg/kg q1wk on Days 1, 8 and 15 as a 30-minute IV infusion.	Part B: Cohort 3, LV 1.0 mg/kg n=2 participants at risk Participants with NSCLC-nonsquamous were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 4, LV 1.0 mg/kg n=2 participants at risk Participants with HNSCC were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.	Part B: Cohort 6, LV 1.0 mg/kg n=2 participants at risk Participants with GEJ were administered LV 1.0 mg/kg on Days 1, 8 and 15 q1wk as a 30-minute IV infusion.
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	16.7% 2/12 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	11.8% 2/17 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	28.6% 6/21 • Number of events 8 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	23.3% 7/30 • Number of events 8 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Blood and lymphatic system disorders Leukopenia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Blood and lymphatic system disorders Neutropenia	20.0% 2/10 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	60.0% 3/5 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	33.3% 4/12 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	18.8% 3/16 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.8% 3/19 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	35.3% 6/17 • Number of events 8 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	9.5% 2/21 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	38.5% 5/13 • Number of events 8 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	26.7% 8/30 • Number of events 10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Cardiac disorders Palpitations	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Cardiac disorders Pericardial effusion	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Cardiac disorders Tachycardia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Ear and labyrinth disorders Tinnitus	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Endocrine disorders Adrenal insufficiency	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Endocrine disorders Androgen deficiency	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Endocrine disorders Hyperprolactinaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Endocrine disorders Hypothyroidism	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Eye disorders Cataract	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Eye disorders Visual impairment	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Abdominal discomfort	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Abdominal pain	30.0% 3/10 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	28.6% 2/7 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	33.3% 4/12 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.8% 3/19 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	23.5% 4/17 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	28.6% 6/21 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	26.7% 8/30 • Number of events 10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	16.7% 2/12 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Ascites	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	9.5% 2/21 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Constipation	20.0% 2/10 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	100.0% 2/2 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	30.8% 4/13 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	40.0% 2/5 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	33.3% 4/12 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	25.0% 4/16 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	21.1% 4/19 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	21.4% 3/14 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	35.3% 6/17 • Number of events 8 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	23.8% 5/21 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	30.8% 4/13 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	43.3% 13/30 • Number of events 13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	46.2% 6/13 • Number of events 9 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	42.9% 3/7 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	40.0% 2/5 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	33.3% 4/12 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	37.5% 6/16 • Number of events 8 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	56.2% 9/16 • Number of events 17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	31.6% 6/19 • Number of events 11 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	35.7% 5/14 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	29.4% 5/17 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	38.1% 8/21 • Number of events 11 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	30.8% 4/13 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	46.7% 14/30 • Number of events 24 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	100.0% 2/2 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Dyspepsia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	9.5% 2/21 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.0% 3/30 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Dysphagia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	11.8% 2/17 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Flatulence	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Gastritis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	21.1% 4/19 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Haematochezia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Hiatus hernia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Melaena	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Nausea	30.0% 3/10 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	61.5% 8/13 • Number of events 10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	42.9% 3/7 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	25.0% 3/12 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	37.5% 6/16 • Number of events 8 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	43.8% 7/16 • Number of events 8 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	57.9% 11/19 • Number of events 13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	42.9% 6/14 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	47.1% 8/17 • Number of events 9 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	42.9% 9/21 • Number of events 11 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	30.8% 4/13 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	53.3% 16/30 • Number of events 22 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Odynophagia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Oesophagitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Oral pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Retching	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	9.5% 2/21 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Swollen tongue	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Tongue ulceration	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Gastrointestinal disorders Vomiting	20.0% 2/10 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	30.8% 4/13 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	18.8% 3/16 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	36.8% 7/19 • Number of events 12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	17.6% 3/17 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	28.6% 6/21 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	26.7% 8/30 • Number of events 8 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Asthenia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	28.6% 2/7 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	13.3% 4/30 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Chest pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Chills	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Face oedema	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Fatigue	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	76.9% 10/13 • Number of events 10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	71.4% 5/7 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	40.0% 2/5 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	16.7% 2/12 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	43.8% 7/16 • Number of events 8 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	56.2% 9/16 • Number of events 11 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	63.2% 12/19 • Number of events 13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 7/14 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	70.6% 12/17 • Number of events 12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	52.4% 11/21 • Number of events 12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	53.8% 7/13 • Number of events 8 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	43.3% 13/30 • Number of events 18 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Gait disturbance	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Influenza like illness	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Injection site irritation	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Localised oedema	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Non-cardiac chest pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Oedema	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Oedema peripheral	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.8% 3/19 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.0% 3/30 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Peripheral swelling	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Pyrexia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	31.2% 5/16 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	35.7% 5/14 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	11.8% 2/17 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.0% 3/30 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Swelling	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
General disorders Swelling face	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Hepatobiliary disorders Jaundice	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Immune system disorders Seasonal allergy	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Bronchitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations COVID-19	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.0% 3/30 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Conjunctivitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Conjunctivitis bacterial	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Escherichia infection	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Gingivitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Herpes simplex	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Lymphangitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Oral candidiasis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Oral fungal infection	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Pneumonia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Pneumonia aspiration	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Rash pustular	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Rhinitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Sputum purulent	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Tooth abscess	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Tooth infection	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Infections and infestations Urinary tract infection	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Injury, poisoning and procedural complications Burns first degree	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Alanine aminotransferase increased	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	9.5% 2/21 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	33.3% 10/30 • Number of events 11 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Aspartate aminotransferase increased	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 3/21 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	23.1% 3/13 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	26.7% 8/30 • Number of events 11 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Blood creatinine increased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	9.5% 2/21 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Blood magnesium decreased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Gamma-glutamyltransferase increased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations International normalised ratio increased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Iron binding capacity total decreased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Liver function test increased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Lymphocyte count decreased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Neutrophil count decreased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	9.5% 2/21 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Troponin increased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Weight decreased	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	23.1% 3/13 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	18.8% 3/16 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.8% 3/19 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	35.3% 6/17 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	19.0% 4/21 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	23.3% 7/30 • Number of events 8 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations Weight increased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Investigations White blood cell count decreased	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Cachexia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Decreased appetite	30.0% 3/10 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	46.2% 6/13 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	57.1% 4/7 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	60.0% 3/5 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	16.7% 2/12 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	43.8% 7/16 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	26.3% 5/19 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	42.9% 6/14 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	58.8% 10/17 • Number of events 12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	38.1% 8/21 • Number of events 9 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	46.2% 6/13 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	36.7% 11/30 • Number of events 12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	100.0% 2/2 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	30.8% 4/13 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	28.6% 2/7 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Gout	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hypercreatininaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hyperglycaemia	20.0% 2/10 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	31.2% 5/16 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 6/30 • Number of events 9 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hypokalaemia	30.0% 3/10 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	30.8% 4/13 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	18.8% 3/16 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	26.3% 5/19 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	9.5% 2/21 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	23.1% 3/13 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	100.0% 2/2 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	30.8% 4/13 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	25.0% 4/16 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.8% 3/19 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hyponatraemia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	21.1% 4/19 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	11.8% 2/17 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Metabolism and nutrition disorders Malnutrition	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	28.6% 2/7 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	18.8% 3/16 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	18.8% 3/16 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.8% 3/19 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	11.8% 2/17 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 3/21 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	16.7% 5/30 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 6/30 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	23.1% 3/13 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Myalgia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	40.0% 2/5 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	16.7% 2/12 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	18.8% 3/16 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	21.4% 3/14 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	16.7% 5/30 • Number of events 10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.8% 3/19 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	11.8% 2/17 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.0% 3/30 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	9.5% 2/21 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Amnesia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Aphasia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Asterixis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Disturbance in attention	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Dizziness	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.8% 3/19 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	11.8% 2/17 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Dizziness postural	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Dysarthria	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Dysgeusia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	9.5% 2/21 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Headache	20.0% 2/10 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	13.3% 4/30 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Hypogeusia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Lethargy	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Lumbar radiculopathy	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Memory impairment	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Neuralgia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Neurotoxicity	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Paraesthesia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	18.8% 3/16 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	13.3% 4/30 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Peripheral sensorimotor neuropathy	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Peripheral sensory neuropathy	10.0% 1/10 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	23.1% 3/13 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	40.0% 2/5 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	25.0% 3/12 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	25.0% 4/16 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	36.8% 7/19 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 7/14 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	17.6% 3/17 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	33.3% 7/21 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	23.1% 3/13 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 15/30 • Number of events 17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Sciatica	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Seizure	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Syncope	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Taste disorder	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Transient ischaemic attack	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Nervous system disorders Tremor	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Psychiatric disorders Anxiety	10.0% 1/10 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Psychiatric disorders Confusional state	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Psychiatric disorders Delirium	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Psychiatric disorders Depression	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Psychiatric disorders Hallucination	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	40.0% 2/5 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.8% 3/19 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	17.6% 3/17 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	19.0% 4/21 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	30.8% 4/13 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 6/30 • Number of events 6 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Psychiatric disorders Poor quality sleep	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Renal and urinary disorders Chromaturia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Renal and urinary disorders Dysuria	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Renal and urinary disorders Haematuria	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Renal and urinary disorders Hydronephrosis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Renal and urinary disorders Micturition urgency	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Renal and urinary disorders Urinary retention	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Reproductive system and breast disorders Genital burning sensation	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 2/10 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	12.5% 2/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	21.1% 4/19 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	21.4% 3/14 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Dysphonia	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	30.0% 3/10 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	30.8% 4/13 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	40.0% 2/5 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	25.0% 4/16 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	25.0% 4/16 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	26.3% 5/19 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	17.6% 3/17 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	23.1% 3/13 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	100.0% 2/2 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Hiccups	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Laryngeal ventricle prolapse	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	40.0% 2/5 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	16.7% 2/12 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Alopecia	30.0% 3/10 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	38.5% 5/13 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	57.1% 4/7 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	58.3% 7/12 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	18.8% 3/16 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	31.2% 5/16 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	26.3% 5/19 • Number of events 5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	28.6% 4/14 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	41.2% 7/17 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	33.3% 7/21 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	30.8% 4/13 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	56.7% 17/30 • Number of events 18 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Pruritus	20.0% 2/10 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 1/7 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	17.6% 3/17 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	13.3% 4/30 • Number of events 7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	15.4% 2/13 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.5% 2/19 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 2/14 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	14.3% 3/21 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.2% 1/16 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Skin maceration	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Skin toxicity	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	10.0% 1/10 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	20.0% 1/5 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	16.7% 2/12 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Vascular disorders Arterial occlusive disease	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Vascular disorders Flushing	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	3.3% 1/30 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Vascular disorders Hypertension	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.1% 1/14 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	4.8% 1/21 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	10.0% 3/30 • Number of events 3 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Vascular disorders Hypotension	20.0% 2/10 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	7.7% 1/13 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/12 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.3% 1/19 • Number of events 4 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	5.9% 1/17 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	6.7% 2/30 • Number of events 2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	50.0% 1/2 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.
Vascular disorders Raynaud's phenomenon	0.00% 0/10 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/7 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/5 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	8.3% 1/12 • Number of events 1 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/16 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/19 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/14 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/17 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/21 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/13 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/30 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.	0.00% 0/2 • From start of study treatment up to 30 days after last dose of study treatment (maximum up to 37.5 months) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. All-cause mortality included all enrolled participants. SAEs and non-SAEs were analyzed in the safety analysis set. The safety analysis set included all participants who received any amount of study drug.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place