Trial Outcomes & Findings for An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread (NCT NCT03446040)

NCT ID: NCT03446040

Last Updated: 2025-09-18

Results Overview

An Adverse Event (AE) is any new untoward medical occurrence or worsening of a preexisting medical condition in a study participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event) * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 92 participants
• Primary outcome timeframe: From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)
• Results posted on: 2025-09-18

Participant Flow

Participants were treated in Part A, Part A1, and Part B. No participants were enrolled or treated in Part C. 4 participants in Part A1 transitioned to Part B.

Participant milestones

Measure	Part A: BMS-986258 8 mg Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Overall Study STARTED	3	3	4	4	4	9	3	5	8	4	11	4	15	15
Overall Study Transitioned From Part A1	0	0	0	0	0	0	0	0	0	0	0	2	2	0
Overall Study COMPLETED	0	0	0	0	0	0	0	0	4	0	1	0	8	6
Overall Study NOT COMPLETED	3	3	4	4	4	9	3	5	4	4	10	4	7	9

Reasons for withdrawal

Measure	Part A: BMS-986258 8 mg Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Overall Study Disease progression	3	3	3	4	4	6	3	4	2	4	9	3	7	7
Overall Study Study drug toxicity	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Overall Study Adverse Event	0	0	0	0	0	2	0	0	1	0	0	0	0	0
Overall Study Death	0	0	0	0	0	0	0	0	0	0	1	0	0	2
Overall Study Participant requested to discontinue study treatment	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Overall Study Participant withdrew consent	0	0	0	0	0	1	0	1	0	0	0	0	0	0
Overall Study Not reported	0	0	1	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

Baseline characteristics by cohort

Measure	Part A: BMS-986258 8 mg n=3 Participants Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=3 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg n=4 Participants Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg n=4 Participants Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg n=4 Participants Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg n=9 Participants Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg n=3 Participants Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg n=5 Participants Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg n=8 Participants Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg n=4 Participants Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg n=11 Participants Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg n=4 Participants Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg n=15 Participants Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE n=15 Participants Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Total n=92 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 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	1 Participants n=24 Participants
Age, Continuous	60.7 Years STANDARD_DEVIATION 16.17 • n=5 Participants	45.7 Years STANDARD_DEVIATION 6.03 • n=7 Participants	61.5 Years STANDARD_DEVIATION 3.11 • n=5 Participants	67.0 Years STANDARD_DEVIATION 4.24 • n=4 Participants	60 Years STANDARD_DEVIATION 12.44 • n=21 Participants	61.1 Years STANDARD_DEVIATION 7.10 • n=8 Participants	65.3 Years STANDARD_DEVIATION 8.33 • n=8 Participants	54.8 Years STANDARD_DEVIATION 8.07 • n=24 Participants	58.4 Years STANDARD_DEVIATION 5.85 • n=42 Participants	64.5 Years STANDARD_DEVIATION 5.07 • n=42 Participants	62.5 Years STANDARD_DEVIATION 7.75 • n=42 Participants	57.3 Years STANDARD_DEVIATION 16.2 • n=42 Participants	58.5 Years STANDARD_DEVIATION 15.0 • n=36 Participants	57.8 Years STANDARD_DEVIATION 12.27 • n=36 Participants	59.6 Years STANDARD_DEVIATION 10.62 • n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	5 Participants n=36 Participants	4 Participants n=36 Participants	35 Participants n=24 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants	6 Participants n=42 Participants	2 Participants n=42 Participants	8 Participants n=42 Participants	2 Participants n=42 Participants	10 Participants n=36 Participants	11 Participants n=36 Participants	57 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	1 Participants n=36 Participants	4 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	3 Participants n=21 Participants	8 Participants n=8 Participants	3 Participants n=8 Participants	5 Participants n=24 Participants	8 Participants n=42 Participants	3 Participants n=42 Participants	10 Participants n=42 Participants	4 Participants n=42 Participants	11 Participants n=36 Participants	14 Participants n=36 Participants	82 Participants n=24 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	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=36 Participants	0 Participants n=36 Participants	6 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 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	1 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=36 Participants	3 Participants n=36 Participants	22 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants	2 Participants n=36 Participants	9 Participants n=24 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	7 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 Participants	5 Participants n=42 Participants	3 Participants n=42 Participants	8 Participants n=42 Participants	2 Participants n=42 Participants	8 Participants n=36 Participants	10 Participants n=36 Participants	55 Participants n=24 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
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	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants	0 Participants n=36 Participants	4 Participants n=24 Participants

PRIMARY outcome

Timeframe: From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)

Population: All treated participants. Participants who started in the Part A1 group but transitioned to Part B are accounted for in both treatment groups.

An Adverse Event (AE) is any new untoward medical occurrence or worsening of a preexisting medical condition in a study participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose:

• Results in death
• Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event)
• Requires inpatient hospitalization or causes prolongation of existing hospitalization
• Results in persistent or significant disability/incapacity
• Is a congenital anomaly/birth defect.

Outcome measures

Measure	Part A: BMS-986258 8 mg n=3 Participants Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=3 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg n=4 Participants Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg n=4 Participants Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg n=4 Participants Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg n=9 Participants Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg n=3 Participants Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg n=5 Participants Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg n=8 Participants Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg n=4 Participants Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg n=11 Participants Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg n=6 Participants Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg n=17 Participants Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE n=15 Participants Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Number of Participants With Adverse Events (AEs) Serious Adverse Events (SAEs)	1 Participants	2 Participants	3 Participants	1 Participants	0 Participants	4 Participants	1 Participants	3 Participants	2 Participants	2 Participants	6 Participants	1 Participants	6 Participants	3 Participants
Number of Participants With Adverse Events (AEs) Adverse Events (AEs)	3 Participants	3 Participants	4 Participants	4 Participants	4 Participants	8 Participants	2 Participants	5 Participants	8 Participants	4 Participants	11 Participants	6 Participants	17 Participants	13 Participants
Number of Participants With Adverse Events (AEs) Adverse Events (AEs) leading to discontinuation of study treatment	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose until death due to any cause (up to approximately 78 months)

Population: All treated participants. Participants who crossed over from part A1 are accounted for under their original arm assignment.

The number of participants who died during the study.

Outcome measures

Measure	Part A: BMS-986258 8 mg n=3 Participants Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=3 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg n=4 Participants Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg n=4 Participants Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg n=4 Participants Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg n=9 Participants Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg n=3 Participants Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg n=5 Participants Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg n=8 Participants Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg n=4 Participants Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg n=11 Participants Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg n=4 Participants Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg n=15 Participants Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE n=15 Participants Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Number of Participants Who Died During the Study	3 Participants	3 Participants	3 Participants	3 Participants	3 Participants	7 Participants	3 Participants	4 Participants	5 Participants	3 Participants	9 Participants	0 Participants	10 Participants	8 Participants

PRIMARY outcome

Timeframe: From first dose (Cycle 1 Day 1) until day 28 (Cycle 1 Day 28)

Population: All treated participants who were evaluable for DLTs.

Dose-limiting toxicity (DLT) refers to a side effect or adverse reaction caused by a drug that is severe enough to prevent an increase in dose or level of that drug. It is typically identified during clinical trials to determine the highest dose of a drug that can be given safely without causing unacceptable side effects.

A participant was considered DLT evaluable if they received 1 dose of BMS-986258 in Part A or 1 dose of BMS-986258 and nivolumab 480mg in Part B and completed the DLT observation period.

Participants who withdraw from the study during the 4-week DLT evaluation period for reasons other than a DLT may be replaced with a new participant at the same dose level.

Outcome measures

Measure	Part A: BMS-986258 8 mg n=3 Participants Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=3 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg n=4 Participants Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg n=4 Participants Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg n=3 Participants Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg n=4 Participants Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg n=3 Participants Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg n=3 Participants Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg n=5 Participants Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg n=3 Participants Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg n=5 Participants Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg n=2 Participants Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg n=5 Participants Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE n=1 Participants Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Number of Participants With Dose Limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first dose until disease progression or death, whichever occurred first (up to approximately 78 months)

Population: All treated participants. Prespecified to be reported collectively per Part. Participants who crossed over from part A1 to Part B are accounted for in both arms.

Objective response rate (ORR) is defined as the percent of treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per RECIST v1.1.

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

Outcome measures

Measure	Part A: BMS-986258 8 mg n=43 Participants Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=37 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg n=15 Participants Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Objective Response Rate (ORR)	0 Percent of Participants Interval 0.0 to 8.22	5.4 Percent of Participants Interval 0.66 to 18.19	0 Percent of Participants Interval 0.0 to 21.8	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first dose until disease progression or death whichever occurred first (up to approximately 78 months)

Population: All treated participants witha complete or partial response. Prespecified to be reported collectively per Part. Response evaluable participants who crossed over from part A1 to Part B are accounted for in both arms.

Median duration of response (mDOR) for a participant with a best overall response (BOR) of complete response (CR) or partial response (PR) is defined as the time between the date of first response and the date of the first objectively documented disease progression (DP) per RECIST v1.1 or death, whichever occurred first.

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

Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.

Based on Kaplan-Meier estimates.

Outcome measures

Measure	Part A: BMS-986258 8 mg Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=2 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Median Duration of Response (mDOR)	—	NA Months Insufficient number of events to calculate median, LL, and UL by K-M methodology.	—	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At 6, 9, and 12 months after first dose

Population: All treated participants. Prespecified to be reported collectively per Part. Treated participants who crossed over from part A1 to Part B are accounted for in both arms.

Progression free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurred first.

Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.

Outcome measures

Measure	Part A: BMS-986258 8 mg n=43 Participants Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=37 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg n=15 Participants Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Progression-Free Survival (PFS) Rate at 6, 9, and 12 Months 6-month	21.4 Percent of Participants Interval 9.3 to 36.8	21.9 Percent of Participants Interval 8.4 to 39.3	8.7 Percent of Participants Interval 0.5 to 32.0	—	—	—	—	—	—	—	—	—	—	—
Progression-Free Survival (PFS) Rate at 6, 9, and 12 Months 9-month	17.1 Percent of Participants Interval 6.2 to 32.6	8.2 Percent of Participants Interval 0.8 to 27.7	8.7 Percent of Participants Interval 0.5 to 32.0	—	—	—	—	—	—	—	—	—	—	—
Progression-Free Survival (PFS) Rate at 6, 9, and 12 Months 12-month	17.1 Percent of Participants Interval 6.2 to 32.6	0.0 Percent of Participants 95% CI not calculated as PFS-Rate = 0%	0.0 Percent of Participants 95% CI not calculated as PFS-Rate = 0%	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)

Population: All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.

Cmax (Maximum Concentration) is the highest level of a drug in the blood after it has been taken. It shows the peak level of the drug, which helps in understanding how much of the drug is absorbed and how strong its effects might be.

Outcome measures

Measure	Part A: BMS-986258 8 mg n=3 Participants Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=3 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg n=4 Participants Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg n=4 Participants Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg n=4 Participants Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg n=9 Participants Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg n=3 Participants Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg n=5 Participants Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg n=8 Participants Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg n=4 Participants Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg n=10 Participants Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg n=3 Participants Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg n=15 Participants Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE n=9 Participants Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Maximum Plasma Concentration (Cmax) of BMS-986258 Cycle 1 Day 1	2.27 ug/mL Geometric Coefficient of Variation 53.8	5.34 ug/mL Geometric Coefficient of Variation 36.2	31.5 ug/mL Geometric Coefficient of Variation 10.9	47.2 ug/mL Geometric Coefficient of Variation 120	121 ug/mL Geometric Coefficient of Variation 30.7	239 ug/mL Geometric Coefficient of Variation 35.6	423 ug/mL Geometric Coefficient of Variation 12.9	412 ug/mL Geometric Coefficient of Variation 26.7	890 ug/mL Geometric Coefficient of Variation 29.2	154 ug/mL Geometric Coefficient of Variation 43.4	244 ug/mL Geometric Coefficient of Variation 24.8	449 ug/mL Geometric Coefficient of Variation 31.5	579 ug/mL Geometric Coefficient of Variation 19.4	121 ug/mL Geometric Coefficient of Variation 44.1
Maximum Plasma Concentration (Cmax) of BMS-986258 Cycle 3 Day 1	—	9.26 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	—	50 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	—	356 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	—	—	605 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	111 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	161 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	422 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	684 ug/mL Geometric Coefficient of Variation 18.1	—
Maximum Plasma Concentration (Cmax) of BMS-986258 Cycle 1 Day 29	—	—	—	—	—	—	—	—	—	—	—	—	—	479 ug/mL Geometric Coefficient of Variation 21.2

SECONDARY outcome

Timeframe: Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)

Population: All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.

AUC (0-T) is the total exposure to the drug over a specific period; from the time you take it until a specified time.

It helps in understanding the overall amount of drug that has been in your body over that time period.

Outcome measures

Measure	Part A: BMS-986258 8 mg n=3 Participants Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=3 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg n=4 Participants Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg n=4 Participants Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg n=4 Participants Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg n=9 Participants Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg n=3 Participants Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg n=5 Participants Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg n=8 Participants Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg n=4 Participants Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg n=10 Participants Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg n=3 Participants Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg n=15 Participants Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE n=9 Participants Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258 Cycle 1 Day 29	—	—	—	—	—	—	—	—	—	—	—	—	—	138000 h*ug/mL Geometric Coefficient of Variation 21
Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258 Cycle 1 Day 1	53.7 h*ug/mL Geometric Coefficient of Variation 50.8	457 h*ug/mL Geometric Coefficient of Variation 56	4690 h*ug/mL Geometric Coefficient of Variation 43.3	8180 h*ug/mL Geometric Coefficient of Variation 101	26100 h*ug/mL Geometric Coefficient of Variation 46.7	46000 h*ug/mL Geometric Coefficient of Variation 83.9	97000 h*ug/mL Geometric Coefficient of Variation 23.3	75300 h*ug/mL Geometric Coefficient of Variation 44.5	179000 h*ug/mL Geometric Coefficient of Variation 24.3	29000 h*ug/mL Geometric Coefficient of Variation 51.4	44300 h*ug/mL Geometric Coefficient of Variation 34.9	84100 h*ug/mL Geometric Coefficient of Variation 83.2	118000 h*ug/mL Geometric Coefficient of Variation 25.4	48500 h*ug/mL Geometric Coefficient of Variation 51.1
Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258 Cycle 3 Day 1	—	1400 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	—	13400 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	—	102000 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	—	—	135000 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	29800 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	38200 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	89000 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	171000 h*ug/mL Geometric Coefficient of Variation 27	—

SECONDARY outcome

Timeframe: Part A and B: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)

Population: All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.

AUC(TAU) (Area Under the Curve over the Dosing Interval) is the total exposure to the drug over one complete dosing interval (the time between doses). It helps in understanding how much of the drug is in your body over the entire period between doses, which is important for determining the right dosing schedule.

Outcome measures

Measure	Part A: BMS-986258 8 mg Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=3 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg n=4 Participants Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg n=4 Participants Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg n=4 Participants Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg n=8 Participants Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg n=3 Participants Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg n=5 Participants Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg n=8 Participants Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg n=4 Participants Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg n=10 Participants Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg n=3 Participants Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg n=15 Participants Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE n=7 Participants Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Area Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258 Cycle 1 Day 1	—	587 h*ug/mL Geometric Coefficient of Variation 41.9	4870 h*ug/mL Geometric Coefficient of Variation 43.7	8400 h*ug/mL Geometric Coefficient of Variation 105	26900 h*ug/mL Geometric Coefficient of Variation 47.4	56400 h*ug/mL Geometric Coefficient of Variation 45	100000 h*ug/mL Geometric Coefficient of Variation 18	85800 h*ug/mL Geometric Coefficient of Variation 21.9	187000 h*ug/mL Geometric Coefficient of Variation 29.5	29000 h*ug/mL Geometric Coefficient of Variation 51.4	47300 h*ug/mL Geometric Coefficient of Variation 29.4	89600 h*ug/mL Geometric Coefficient of Variation 67.9	120000 h*ug/mL Geometric Coefficient of Variation 22.5	46200 h*ug/mL Geometric Coefficient of Variation 53.9
Area Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258 Cycle 3 Day 1	—	1440 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	—	13400 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	—	102000 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	—	—	135000 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	18600 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	38200 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	89000 h*ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	172000 h*ug/mL Geometric Coefficient of Variation 26.1	—
Area Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258 Cycle 1 Day 29	—	—	—	—	—	—	—	—	—	—	—	—	—	134000 h*ug/mL Geometric Coefficient of Variation 17.3

SECONDARY outcome

Timeframe: Part A and B: On Cycle 1 Day 29 and Cycle 3 Day 29 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 29 and Cycle 2 Day 1 predose (1 cycle = 8 weeks)

Population: All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.

Ctau (Concentration at the End of the Dosing Interval) is the level of the drug in the blood just before the next dose is due. It shows how much of the drug remains in your body before taking the next dose, which helps in ensuring that the drug levels stay effective without dropping too low.

Outcome measures

Measure	Part A: BMS-986258 8 mg Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=3 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg n=4 Participants Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg n=4 Participants Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg n=4 Participants Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg n=8 Participants Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg n=3 Participants Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg n=5 Participants Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg n=8 Participants Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg n=4 Participants Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg n=10 Participants Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg n=3 Participants Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg n=15 Participants Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE n=7 Participants Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Concentration at the End of the Dosing Interval (Ctau) of BMS-986258 Cycle 1 Day 29 predose	—	0.0245 ug/mL Geometric Coefficient of Variation 52.3	1.58 ug/mL Geometric Coefficient of Variation 116	2.59 ug/mL Geometric Coefficient of Variation 369	15.5 ug/mL Geometric Coefficient of Variation 68.6	37.2 ug/mL Geometric Coefficient of Variation 62.9	55.7 ug/mL Geometric Coefficient of Variation 55.2	36.9 ug/mL Geometric Coefficient of Variation 68.5	109 ug/mL Geometric Coefficient of Variation 44.6	15.6 ug/mL Geometric Coefficient of Variation 82.3	23.5 ug/mL Geometric Coefficient of Variation 70.3	39.8 ug/mL Geometric Coefficient of Variation 229	68.4 ug/mL Geometric Coefficient of Variation 47.1	37.7 ug/mL Geometric Coefficient of Variation 80.2
Concentration at the End of the Dosing Interval (Ctau) of BMS-986258 Cycle 3 Day 29 predose	—	0.0711 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	—	8.32 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	—	80.3 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	—	—	71.3 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	7.77 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	25 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	37.1 ug/mL Geometric Coefficient of Variation NA Insufficient number of participants to calculate geometric CV	121 ug/mL Geometric Coefficient of Variation 36.6	—
Concentration at the End of the Dosing Interval (Ctau) of BMS-986258 Cycle 2 Day 1 predose	—	—	—	—	—	—	—	—	—	—	—	—	—	114 ug/mL Geometric Coefficient of Variation 13

SECONDARY outcome

Timeframe: Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)

Population: All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.

Tmax (Time to Reach Maximum Concentration) is the time it takes for the drug to reach its highest level in the blood after taking it. It helps in understanding how quickly the drug starts to work and reaches its peak effect.

Outcome measures

Measure	Part A: BMS-986258 8 mg n=3 Participants Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=3 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg n=4 Participants Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg n=4 Participants Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg n=4 Participants Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg n=9 Participants Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg n=3 Participants Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg n=5 Participants Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg n=8 Participants Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg n=4 Participants Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg n=10 Participants Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg n=3 Participants Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg n=15 Participants Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE n=9 Participants Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Time to Reach Maximum Concentration (Tmax) of BMS-986258 Cycle 1 Day 1	0.808 Hours Interval 0.033 to 4.0	1.23 Hours Interval 0.117 to 4.0	1.4 Hours Interval 0.45 to 4.0	2.11 Hours Interval 0.45 to 24.5	3.92 Hours Interval 0.617 to 24.0	0.998 Hours Interval 0.467 to 4.13	1.09 Hours Interval 0.467 to 4.38	1.47 Hours Interval 1.47 to 1.48	3.11 Hours Interval 2.0 to 4.05	0.812 Hours Interval 0.467 to 4.0	4.18 Hours Interval 4.0 to 4.58	1.02 Hours Interval 0.983 to 1.07	2.29 Hours Interval 1.47 to 5.52	123 Hours Interval 72.2 to 168.0
Time to Reach Maximum Concentration (Tmax) of BMS-986258 Cycle 3 Day 1	—	4 Hours Interval 4.0 to 4.0	—	0.7 Hours Interval 0.7 to 0.7	—	4.27 Hours Interval 4.0 to 4.55	—	—	2 Hours Interval 2.0 to 2.0	0.499 Hours Interval 0.467 to 0.533	0.467 Hours Interval 0.467 to 0.467	2.02 Hours Interval 1.02 to 4.0	2.74 Hours Interval 1.47 to 5.48	—
Time to Reach Maximum Concentration (Tmax) of BMS-986258 Cycle 1 Day 29	—	—	—	—	—	—	—	—	—	—	—	—	—	1.26 Hours Interval 0.967 to 2.33

SECONDARY outcome

Timeframe: From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)

Population: All treated participants with baseline and at least one post-baseline pre-infusion ADA assessment. Prespecified to be reported collectively per Part. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms.

Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment

Outcome measures

Measure	Part A: BMS-986258 8 mg n=35 Participants Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 24 mg n=28 Participants Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 72 mg n=14 Participants Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 200 mg Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 480 mg Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 800 mg Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1200 mg Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 1600 mg Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A: BMS-986258 2400 mg Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 480 mg + NIVO 480 mg Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 800 mg + NIVO 480 mg Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1200 mg + NIVO 480 mg Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part B: BMS-986258 1600 mg + NIVO 480 mg Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1: BMS-986258 1200 mg + ENHANZE Participant received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).
Number of Participants With Anti-Drug Antibodies to BMS-986258 or Nivolumab Baseline ADA positive: BMS-986258	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Anti-Drug Antibodies to BMS-986258 or Nivolumab ADA positive: BMS-986258	2 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Anti-Drug Antibodies to BMS-986258 or Nivolumab Baseline ADA positive: nivolumab	—	1 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—
Number of Participants With Anti-Drug Antibodies to BMS-986258 or Nivolumab ADA positive: nivolumab	—	2 Participants	0 Participants	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Part A: BMS-986258 8 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 3 deaths

Part A: BMS-986258 24 mg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 3 deaths

Part A: BMS-986258 72 mg

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

Part A: BMS-986258 200 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 3 deaths

Part A: BMS-986258 480 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 3 deaths

Part A: BMS-986258 800 mg

Serious events: 4 serious events

Other events: 8 other events

Deaths: 7 deaths

Part A: BMS-986258 1200 mg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 3 deaths

Part A: BMS-986258 1600 mg

Serious events: 3 serious events

Other events: 5 other events

Deaths: 4 deaths

Part A: BMS-986258 2400 mg

Serious events: 2 serious events

Other events: 8 other events

Deaths: 5 deaths

Part B: BMS-986258 480 mg + NIVO 480 mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 3 deaths

Part B: BMS-986258 800 mg + NIVO 480 mg

Serious events: 6 serious events

Other events: 9 other events

Deaths: 9 deaths

Part B: BMS-986258 1200 mg + NIVO 480 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Part B: BMS-986258 1600 mg + NIVO 480 mg

Serious events: 6 serious events

Other events: 15 other events

Deaths: 10 deaths

Part A1: BMS-986258 1200 mg + ENHANZE

Serious events: 3 serious events

Other events: 9 other events

Deaths: 7 deaths

Part A1 Crossover to Part B: 1200 mg BMS + 480 mg Nivo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Part A1 Crossover to Part B: 1600 mg BMS + 480 mg Nivo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part A: BMS-986258 8 mg n=3 participants at risk Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 24 mg n=3 participants at risk Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 72 mg n=4 participants at risk Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 200 mg n=4 participants at risk Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 480 mg n=4 participants at risk Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 800 mg n=9 participants at risk Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 1200 mg n=3 participants at risk Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 1600 mg n=5 participants at risk Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 2400 mg n=8 participants at risk Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part B: BMS-986258 480 mg + NIVO 480 mg n=4 participants at risk Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part B: BMS-986258 800 mg + NIVO 480 mg n=11 participants at risk Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part B: BMS-986258 1200 mg + NIVO 480 mg n=4 participants at risk Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part B: BMS-986258 1600 mg + NIVO 480 mg n=15 participants at risk Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A1: BMS-986258 1200 mg + ENHANZE n=11 participants at risk Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A1 Crossover to Part B: 1200 mg BMS + 480 mg Nivo n=2 participants at risk Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle. Upon crossover, participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for a total treatment duration of up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1 Crossover to Part B: 1600 mg BMS + 480 mg Nivo n=2 participants at risk Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle. Upon crossover, participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for a total treatment duration of up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Cardiac disorders Angina pectoris	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Asthenia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Death	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Face oedema	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Fatigue	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders General physical health deterioration	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Multiple organ dysfunction syndrome	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Hepatobiliary disorders Biliary obstruction	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Pneumonia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Sepsis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Skin infection	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Vascular device infection	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Alanine aminotransferase increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Blood bilirubin increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 2/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 3/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	18.2% 2/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Asterixis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Ataxia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Cognitive disorder	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Myelopathy	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Myoclonus	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Psychiatric disorders Confusional state	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Renal and urinary disorders Haematuria	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.

Other adverse events

Measure	Part A: BMS-986258 8 mg n=3 participants at risk Participants received 8 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 24 mg n=3 participants at risk Participants received 24 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 72 mg n=4 participants at risk Participants received 72 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 200 mg n=4 participants at risk Participants received 200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 480 mg n=4 participants at risk Participants received 480 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 800 mg n=9 participants at risk Participants received 800 mg BMS-986258 IV every 4 weeks (Q4W) for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 1200 mg n=3 participants at risk Participants received 1200 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 1600 mg n=5 participants at risk Participants received 1600 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A: BMS-986258 2400 mg n=8 participants at risk Participants received 2400 mg BMS-986258 IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part B: BMS-986258 480 mg + NIVO 480 mg n=4 participants at risk Participants received 480 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part B: BMS-986258 800 mg + NIVO 480 mg n=11 participants at risk Participants received 800 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part B: BMS-986258 1200 mg + NIVO 480 mg n=4 participants at risk Participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part B: BMS-986258 1600 mg + NIVO 480 mg n=15 participants at risk Participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A1: BMS-986258 1200 mg + ENHANZE n=11 participants at risk Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle for up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).	Part A1 Crossover to Part B: 1200 mg BMS + 480 mg Nivo n=2 participants at risk Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle. Upon crossover, participants received 1200 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for a total treatment duration of up to 96 weeks (12 treatment cycles (each cycle = 8 weeks)).	Part A1 Crossover to Part B: 1600 mg BMS + 480 mg Nivo n=2 participants at risk Participants received 1200 mg BMS-986258 with rHuPH20 (ENHANZE) SC for the first dose in Cycle 1. All subsequent doses of BMS-986258 were received as monotherapy IV, every 4 weeks (Q4W) twice per cycle. Upon crossover, participants received 1600 mg BMS-986258 and 480 mg nivolumab IV every 4 weeks (Q4W) twice per cycle for a total treatment duration of up to 96 weeks (12 treatment cycles (each cycle = 8 weeks).
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	100.0% 2/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Endocrine disorders Hypothyroidism	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Eye disorders Cataract	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Eye disorders Eyelid ptosis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Eye disorders Vision blurred	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	66.7% 2/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 2/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Ascites	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Cheilitis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Constipation	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	27.3% 3/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 3/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	66.7% 2/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 2/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	27.3% 3/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Eructation	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Lip dry	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Nausea	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 2/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	40.0% 2/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	36.4% 4/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	100.0% 2/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	100.0% 2/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Rectal discharge	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Salivary duct inflammation	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Gastrointestinal disorders Vomiting	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	66.7% 2/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	37.5% 3/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Chills	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Facial pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Fatigue	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	75.0% 3/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 2/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	44.4% 4/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	37.5% 3/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	54.5% 6/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	26.7% 4/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	27.3% 3/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Injection site reaction	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Malaise	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Mucosal inflammation	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Non-cardiac chest pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	18.2% 2/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Oedema peripheral	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Peripheral swelling	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
General disorders Pyrexia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Immune system disorders Hypersensitivity	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Bronchitis	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations COVID-19	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Candida infection	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Cystitis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Folliculitis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Fungal infection	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Oral herpes	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Pneumonia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Tooth abscess	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Infections and infestations Urinary tract infection	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 2/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 2/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Injury, poisoning and procedural complications Drain site complication	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Alanine aminotransferase increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Amylase increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	37.5% 3/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Blood bilirubin increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Blood creatine phosphokinase increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Blood creatinine increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	18.2% 2/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Blood iron decreased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Blood pressure increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Blood urea increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations C-reactive protein increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Lipase increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Lymphocyte count decreased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	22.2% 2/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Platelet count decreased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Troponin increased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations Weight decreased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Investigations White blood cell count decreased	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 2/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 2/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	22.2% 2/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	40.0% 2/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	62.5% 5/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	27.3% 3/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	40.0% 2/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	18.2% 2/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	18.2% 2/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	18.2% 2/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Musculoskeletal and connective tissue disorders Limb mass	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	22.2% 2/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Dizziness	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Dysgeusia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Headache	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Lethargy	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Paraesthesia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Seizure	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Nervous system disorders Tremor	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Psychiatric disorders Anxiety	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Psychiatric disorders Confusional state	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Psychiatric disorders Depression	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Psychiatric disorders Insomnia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Renal and urinary disorders Calculus bladder	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Renal and urinary disorders Chromaturia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Renal and urinary disorders Nephrolithiasis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Renal and urinary disorders Urinary hesitation	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Reproductive system and breast disorders Testicular pain	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	66.7% 2/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	40.0% 2/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	22.2% 2/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	18.2% 2/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	18.2% 2/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 3/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	18.2% 2/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Macule	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Onychomadesis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	13.3% 2/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	9.1% 1/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Vascular disorders Hypertension	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	12.5% 1/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	40.0% 2/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 2/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	25.0% 1/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 2/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	26.7% 4/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	50.0% 1/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	33.3% 1/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	6.7% 1/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Vascular disorders Hot flush	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	20.0% 1/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Vascular disorders Systolic hypertension	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.
Vascular disorders Thrombosis	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	11.1% 1/9 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/3 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/5 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/8 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/4 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/15 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/11 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.	0.00% 0/2 • All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks). ACM, SAEs and AEs represent all treated participants. Prespecified for Part A1 crossover participants to be shown separately from those who did not crossover.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please email

Email: Clinical.Trials@bms.com

Results disclosure agreements

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

Restriction type: OTHER